Fda `Politicization` Called Hazardous To Health

October 20, 1985|By Michael L. Millenson, Chicago Tribune.

WASHINGTON — Not long after becoming commissioner of the Food and Drug Administration, Dr. Frank Young gave enlarged replicas of his FDA inspector`s badge to his boss, the secretary of health and human services (HHS), and her chief of staff.

To Young, the gifts were ``thank-yous`` for the help that Secretary Margaret Heckler and the chief of staff, C. McClain Haddow, were giving him in running an agency whose responsibilities range from food, drugs and cosmetics to artificial hearts and computerized brain scanners.

To critics, however, the gifts symbolized what they see as the erosion of the FDA`s traditional independence under the Reagan administration and the growing influence of politics on scientific decisions.

In particular, critics charge that intervention by HHS and the federal Office of Management and Budget (OMB) has endangered public health in activities ranging from eating a salad at a restaurant and giving aspirin to a sick child to applying makeup:

-- Critics say it took congressional hearings spotlighting the death of a 10-year-old girl from an alleged allergic reaction to sulfites before the FDA proposed a limited ban on the preservative, often used to improve the appearance of fruit and vegetables in restaurants.

-- When studies showed that children taking aspirin for flu could develop a potentially fatal disease called Reye`s syndrome, pressure built for mandatory warnings on aspirin bottles. Aspirin makers disputed the studies, and the FDA decided to allow voluntary labeling, which critics now charge manufacturers are ignoring.

-- Although FDA scientists concluded that several dyes and colorings often used in cosmetics were weak carcinogens, HHS and OMB refused to allow the agency to ban their use, a congressional committee found.

In an unusual gesture, Dr. Alexander Schmidt, the FDA commissioner under President Richard Nixon, told state regulators recently, ``We have more politicization of the agency than is either warranted by rational politics or good for the American people.``

One particular target of critics` ire has been Haddow, a former aide to Sen. Orrin Hatch (R., Utah). But Haddow, along with Young, vigorously denies that public health has been threatened in any way.

``We believe without question that science has to be left to the people at FDA,`` says Haddow. ``But we think there`s a role to play in the application of public policy to that science.

``Policy decisions that affect virtually every American deserve to have another level of review. . . . We think the American people have clearly said which philosophy should prevail (in that review).``

To help assure a change in philosophy, a longstanding order giving the FDA commissioner semiautonomous authority was revoked soon after the Reagan administration took office in early 1981. Meanwhile, OMB, which is part of the executive office of the president, stepped up its oversight of the FDA under an executive order requiring an economic ``cost-benefit`` review of government regulations.

The new attention from HHS and OMB was evident when the FDA moved to ban six colorings and dyes found to cause cancer in animals. Although the additives seemed, at worst, to be weak carcinogens, the FDA concluded that the Delaney Clause, a federal law that forbids any use of a carcinogenic food additive, left them no choice.

Nevertheless, a proposed ban was rejected repeatedly by HHS, a report by the House Committee on Government Operations concluded. Meanwhile, an industry trade group attorney with ties to Vice President George Bush intervened with OMB. The FDA then was told that the administration opposed banning the additives, because they were unlikely to cause health problems.

``The administrative record contains no justification from department officials for not approving FDA`s recommendations,`` the House committee said in a unanimous report. ``It is likely that OMB played a major, if not pivotal role, in the continued, unlawful marketing of these dyes.``

Complains Rep. Ted Weiss (D., N.Y.), chairman of a government operations subcommittee: ``It`s not up to the regulatory agency to say they don`t like the law and, therefore, they`re not going to adhere to it.``

Both Republican and Democratic representatives, meanwhile, have asked hard questions about the FDA`s slowness to ban the use of sulfite as a food preservative.

Since early 1983 the FDA has received reports of 21 deaths and more than 800 injuries allegedly caused by allergic reactions to sulfites. In August the agency finally proposed regulations that eventually will ban the preservative in fresh foods and vegetables.

Young insists that the FDA acted as quickly as scientific evidence would allow. ``Sulfites was one of the fastest regulations ever to go through FDA and the department,`` he says.